China NMPA Product Recall - Covered scaffold system

Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall of specific covered stent systems, as announced by the National Medical Products Administration (NMPA) on May 8, 2017. This crucial action stemmed from a identified manufacturing issue where certain models and batches of the covered stents exhibited higher than acceptable membrane permeability. This defect poses a significant concern as it could lead to endoleaks being observed during the stent implantation surgery, potentially impacting patient safety and the intended therapeutic outcome. While specific inspection dates are not detailed, the recall date signifies the company's prompt response to the quality concern. Operating under the NMPA's regulatory oversight, the company's required action was to systematically recall these affected products from the market. Further comprehensive details regarding the specific models, specifications, and batch numbers involved in this recall are formally documented in the accompanying "Medical Device Recall Event Report Form" referenced by the NMPA. This proactive measure underscores Medtronic's commitment to product quality and patient safety within the established regulatory framework.